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This is a Request for Information (RFI) to conduct market research to determine the availability of vendors capable of providing the requirement for certification of primary engineering controls (PECs... This is a Request for Information (RFI) to conduct market research to determine the availability of vendors capable of providing the requirement for certification of primary engineering controls (PECs), secondary engineering controls (SECs), and testing of compounding personnel for aseptic technique by gloved fingertip and thumb sampling, and media fill testing. This requirement is for the James H. Quillen VA Medical Center. This RFI does not guarantee the issuance of an RFQ. If you have the availability to provide the requirement, please respond to this RFI with a capabilities statement. This RFI is issued solely for information and planning purposes. It does not commit the Government to contract for any supply or service whatsoever. The VA is not, at this time, seeking proposals and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested vendor s expense. Not responding to this RFI does not preclude participation in any future RFQ, if any is issued. Any information submitted by respondents to this RFI is strictly voluntary. All submissions become Government property and will not be returned. A - GENERAL INFORMATION A.1 INTRODUCTION The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities and the Joint Commission (TJC) establishes compounding standards for sterile compounded preparations based on the United States Pharmacopeia (USP) standards. The USP establishes standards for sterile compounding room design, environmental monitoring, and competencies for the preparation, handling, and storage of compounded sterile products (CSPs). To meet regulatory requirements in accordance with USP <797> and USP <800>, the James H. Quillen VA Medical Center (JHQVAMC) requires certification of primary engineering controls (PECs), secondary engineering controls (SECs), and testing of compounding personnel for aseptic technique by gloved fingertip and thumb sampling, and media fill testing. A.2 SCOPE OF WORK The Contractor will provide all parts, labor, equipment, material, travel expenses to test and certify the operation and performance of equipment systems and personnel per the Statement of Work listed below. B WORK REQUIREMENTS B.1 TASKS TO BE ACCOMPLISHED: All work must be conducted, coordinated, and scheduled based on the needs of the Pharmacy Service. The testing of the Sterile Compounding Suites and equipment must be conducted during dynamic operating conditions to assure smooth even flow across the DCA and out to the returns. In the presence of the Medication Safety Program Manager. The JHQVAMC will notify the contractor a minimum of 2 business days to a maximum of 5 business days to schedule testing/retesting of the Sterile Compounding Suites and Media Fill Testing/Gloved Fingertip testing. The contractor must respond and be available on site to perform testing/retesting within the specified time frame. The Contractor will provide a Qualified Tester and appropriate tools/test equipment to complete the work as covered in Section C.3. Due to the sensitive nature of the work area, prior to entering sterile compounding areas (buffer room, ante room), the Contractor will maintain a clean work area at all times by wearing appropriate personal protective equipment (set forth by USP <797> standards) and cleaning any equipment with 70% sterile isopropyl alcohol. The Contractor will test each PEC and SEC according to Certification Guide for Sterile Compounding Facilities (CETA) and USP <797> regulations every six months. The Contractor will provide JHQVAMC with the original certification documents that includes all measurements and results of each PEC and SEC. Certification should include identifying information of each PEC and SEC as well as all test equipment used for certification. See Section B for specific requirements. The Contractor will immediately notify identified points of contact (POC) with any results indicating failure. A formalized written report including all required aspects specified in this statement of work will be provided in a timely manner by email with receipt by identified POC no more than 10 business days from certification evaluation. Any failure of engineering controls to meet required specifications shall be clearly marked with a sign that will notify pharmacy staff. B.2 PRIMARY ENGINEERING CONTROLS (PECs) TO CERTIFY PEC tested and certified according to CETA and USP <797> regulations, and to manufacturer s specifications. The contractor will utilize DCA with a NIST traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the POC The Contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration ready of the HEPA filter leak test and the results of the induction leak test and back streaming test. The Contractor will provide and label with a certification sticker that contains the following: company name, phone number, PEC model and serial number, service number, certification date, recertification date, certifiers signature. Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Documentation of test results must also include the number of personnel present in each PEC during testing. Viable Air Sampling shall be conducted with high volume impaction samplers to conduct the sampling of a sufficient volume of air (1000 liters) at each specified location. The reports shall indicate site locations*, volume of air sampled, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU s with locations, identification of CFU s, date & time of sample results. Viable Surface Sampling reports to indicate site locations*, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU s with locations, identification of CFU s, date & time of sample results. Documentation of the smoke study results shall include the number of personnel present in the PEC during the dynamic airflow smoke pattern test. Line Item Description Qty Frequency per Year Qty per Year 1 Restricted Access Barrier- Nu-Aire CAI IV Hood ISO Class 5, Building 77 Room FA126A 1 2 2 2 8 BVBI-8SSRX Laminar Vertical Flow Workstation ISO Class 5, Building 77 Room FA126A 1 2 2 3 6 BBF-6SS Biological Safety Cabinet Class II Type A ISO Class 5, Building 77 Room J140A 1 2 2 B.2A SERVICES TO BE PERFORMED FOR PECs Line Item Description Qty Frequency per Year Qty per Year 1 Total particle count testing under dynamic operating conditions using calibrated electronic equipment for each of the listed PECs. 7 or more 2 varies 2 Viable Air Sampling number and location as determined by the Contractee (bacterial and fungal samples) 8 or more 2 varies 3 Viable Surface Sampling number and location as determined by the Contractee (bacterial and fungal samples) 12 or more 2 varies 4 Both static and dynamic smoke studies verifying a continuous flow of HEPA filtered air void of turbulence, dead air zones, and refluxing from the HEPA filters to and across the entire work area and to the air returns must be performed and documented by video. Video of dynamic smoke test must document the demonstration of unidirectional airflow and sweeping action over and away from the preparation(s). Contractor to leave video of smoke test on site prior to completion of certification process for each of the listed PECs. 3 2 2 5 HEPA filter leak test 3 2 6 6 Cabinet leak test 3 2 6 7 Inflow velocity test to include exhaust airflow volume rate 3 2 6 8 Electrical leakage and ground circuit resistance and polarity tests 3 2 6 9 Lighting intensity test 3 2 6 10 Vibration test 3 2 6 11 Noise level test 3 2 6 12 Ultraviolet (UV) lamp test 3 2 6 13 Airflow testing under dynamic conditions to include air velocity and volume, the air exchange rate. 2 2 6 14 Hazardous drug contamination to include cyclophosphamide, ifosfamide, methotrexate, fluorouracil, taxanes, and platinum-containing drugs. Additional drugs may be requested. 4 2 8 B.3 SECONDARY ENGINEERING CONTROLS (SECs) TO CERTIFY The Contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hours (ACPH) from HVAC, ACPH contributed from the PEC, and the total ACPH for each buffer, ante room, and storage room shall be documented on the certification report. Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Documentation of test results must also include the number of personnel present in each SEC during testing. Viable Air Sampling shall be conducted with high volume impaction samplers to conduct the sampling of a sufficient volume of air (1000 liters) at each specified location. The reports shall indicate site locations*, volume of air sampled, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU s with locations, identification of CFU s, date & time of sample results. Viable Surface Sampling reports to indicate site locations*, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU s with locations, identification of CFU s, date & time of sample results. Hazardous drug contamination sampling report to include manufacturer, lot #, and expiration date of sampling kit, sample site locations, name of products tested for, and results. Line Item Description Qty Frequency per Year (minimum) Qty per Year (minimum) 1 Non-Hazardous IV Anteroom Certification ISO Class 8, Building 77 Room FA126 1 2 2 2 Non-Hazardous IV Buffer Room Certification ISO Class 7, Building 77 Room FA126A 1 2 2 3 Hazardous IV Anteroom Certification ISO Class 7, Building 77 Room J140 1 2 2 4 Hazardous IV Buffer Room Certification ISO Class 7, Building 77 Room J140A 1 2 2 5 Hazardous Drug Storage Room Building 77 Room J139 1 2 2 B.3A SERVICES TO BE PERFORMED FOR SECS Line Item Description Qty Frequency per Year (minimum) Qty per Year (minimum) 1 Total particle count testing under dynamic operating conditions using calibrated electronic equipment, for the SECs 7 or more 2 varies 2 Viable Air Sampling number and location as determined by the Contractee (bacterial and fungal samples) 8 or more 2 varies 3 Viable Surface Sampling number and location as determined by the Contractee (bacterial and fungal samples) 12 or more 2 varies 4 HEPA filter integrity testing 7 2 14 5 Airflow profiling and uniformity testing for listed SECs 2 2 6 Particulate monitoring For listed SECs 2 2 7 Room pressurization monitoring For listed SECs 2 2 8 Temperature and Humidity monitoring For listed SECs 2 2 9 Air pattern analysis For listed SECs 2 2 10 Airflow testing under dynamic conditions to include air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms. For listed SECs 2 2 11 Hazardous drug sampling to include: cyclophosphamide, ifosfamide, methotrexate, fluorouracil, taxanes, and platinum-containing drugs. Additional drugs may be requested. 4 2 8 C SUPPLEMENTAL TESTING Media Fill Testing will occur in Laminar Vertical Flow Workstation in Building 77 Room FA126A and simulate the most difficult and challenging compounding procedures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean casein digest media. A certificate of analysis (COA) must be provided if commercial sterile microbial growth media is used for the media fill testing Initial Certification: gloved fingertip testing will occur after garbing procedures. Media Fill Testing will occur after gloved fingertip. Media Fill Testing will occur prior to gloved fingertip and thumb testing for recertification. The Contractor shall incubate media fill tests in controlled temperature environments in accordance with USP <797> guidance (and <800>). Documentation of the media fill test will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the results. The Contractor shall perform three separate gloved fingertip and thumb tests during initial testing (one sampling device per hand) for each designated employee. Subsequent sampling shall occur every 6 months. Gloved fingertip and thumb samples shall be performed in controlled temperature environments and incubated in accordance with USP <797> and <800> guidance. Each sample shall be labeled with a personnel identifier, whether it was from the right or left hand, and the date and time of sampling. Documentation results for gloved fingertip and thumb sampling will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the number of colony forming units (CFU) for the left and right hand. A formalized written report including all required aspects specified in this statement of work will be provided in a timely manner by email with receipt by identified POC no more than 14 business days for media fill and gloved fingertip tests. Line Item Description Qty Frequency per Year Qty per Year (minimum) 1 Media Fill Testing 25 or more varies 50 2 Gloved Fingertip and thumb testing 25 or more varies 50 D SPECIAL CONSIDERATIONS: D.1 Place of Performance: James H. Quillen VA Medical Center, Corner of Lamont and Veterans Way, Johnson City, Tennessee 37601 D.2 Contractor Furnished Materials: All labor, materials, equipment to perform the job. When furnish , provide , install , or similar term is used it shall mean a complete installation, ready for use. The Contractor shall supply all parts that is currently not covered under warranty, equipment, material and labor to conduct work as listed in the Statement of Work above. The work will include all items as described in the Scope of Work listed above. D.3 Government Furnished Materials and Services: Government furnished property, if any, will be identified and will only be used for the performance of this contract unless otherwise authorized by the Contracting Officer. The Contractor shall, at all times, take any and all steps necessary for maintenance and preservation of all Government-furnished property. The Contractor shall comply with all reasonable requests of the Contracting Officer to enclose, or specifically protect, Government-furnished property. D.4 Qualifications of Key Personnel: The Contractor will provide three references for showing the completion of at least three jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center, in addition will also provide three references for each Qualified Tester that performs work at JHQVAMC. The Contractor s Qualified Tester must possess current CETA, NSF and CNBT Certification for Sterile Compounding Facilities. The Contractor will provide copies of the Qualified Tester s accreditation prior to conducting certification. D.5 Other Requirements: The Contract will provide sample reports of prior certification reports from other contracted Sterile Compounding Suites certifications include Primary and Secondary Engineering Controls. The sample reports should include the calibration reports of equipment used to certify the Sterile Compounding Suites. D.6 Security Requirements: Contractor shall identify which employees will be working under the awarded contract. Contractor personnel shall include employees, sub-contractors, subcontractor employees, suppliers and delivery personnel entering the Medical Center. This does not apply to suppliers and delivery personnel making deliveries to the VA warehouse dock only. Those employees shall bring photo ID to obtain a VA Contractor identification badge that shall be worn above the belt at all times while on Medical Center property. Contractor s employees shall return all I.D. badges to designated personnel at time designated in the task order. D.7 Inspection of Work: The COR is responsible for the inspection of the work called for in this job. The Contracting Officer s Representative will be identified in the task order by name, telephone number and location. Inspections made by the COR are for the sole benefit of the Government and do not relieve the Contractor of any quality control responsibilities. The Contractor will be notified by the Contractee of any updates to identified points of contact list on an as needed basis and in turn the Contractor will provide the Contractee with any updates. D.8 Safety: The Safety Manger is responsible for safety inspections of all contract operations. The Safety Manager will be identified in the task order by name, phone number and location. D.9 Drawings General: Contract drawings (if applicable) will indicate the extent and location of work. If any departure from the contract drawings are deemed necessary by the Contractor, the details of such departure and the reasons therefore shall be submitted to the Contracting Officer for approval as soon as practical. No such departure shall be made without proper written permission of the Contracting Officer. The Contractor is responsible for all information and requirements in drawings and specifications that pertain to the task order. D.10 Verification of Dimensions: The Contractor shall visit the job site to thoroughly familiarize themselves with all the details of the work and working conditions. The Contractor shall also verify all dimensions in the field and shall advise the Contracting Officer of any discrepancy before performing any work. The Contractor shall be specifically responsible for the coordination and proper relation of their work to the building, structure, phasing and ensure the safety of employees and workmen. D.11 Smoking Policy: The Contractor shall ensure employees do no smoke on the VA grounds as JHQVAMC is a smoke-free facility. D.12 Parking/Traffic Regulations: The Contractor shall not park on grassy areas unless approved by the COR and the Contractor agrees to restore areas back to VA standards. Drivers should be particularly concerned with pedestrian traffic. Yield to pedestrians in crosswalks. Posted speed limits and all other traffic controls are to be observed by operators at all times. Seat belt use is mandatory on the VA grounds. Please note that requirements defined to date may change before a final solicitation is released. RFI requirements are as follows: Please acknowledge if your company is an authorized provider of the of the services. Submit responses and related information via email to chaz.bowling@va.gov by 9:30 AM CST, January 17, 2020. Proprietary/Confidential material shall be clearly marked on every page that contains such. Include the name, phone number, and email address of the lead from your organization. VA reserves the right not to respond to any or all emails or materials submitted.